Marks First Health Technology Assessment (HTA) Reimbursement in Europe and Initiation of Next Phase of the Company’s Growth Strategy
Company Provides Progress Update on European and International Expansion Plans
DUBLIN, Ireland and BRIDGEWATER, N.J., March 28, 2022 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announces that the Company received its first national reimbursement in a European country for VAZKEPA® in Sweden and provides an update on the status of its international expansion strategy, including several regulatory filing and reimbursement updates for VASCEPA®/VAZKEPA globally.
“I am pleased to report the first national reimbursement decision for VAZKEPA in Sweden, which marks the beginning of the next phase of growth and expansion outside of the U.S. for Amarin,” commented Karim Mikhail, president and chief executive officer. “This important decision, is a critical milestone as we begin to unlock a multi-billion dollar* revenue opportunity for VASCEPA/VAZKEPA outside of the U.S., as part of our bold ambition to lead a new paradigm in preventive cardiovascular care and grow our impact for patients globally.”
Europe
On March 25, 2022, Amarin received official confirmation that the Swedish Dental and Pharmaceutical Benefits Agency (TLV) approved VAZKEPA (icosapent ethyl) for national reimbursement in Sweden, restricted to the treatment of statin-treated patients with established cardiovascular disease (eCVD) and elevated triglycerides (≥ 150 mg/dl [≥ 1.7 mmol/l]), which represents approximately 70% of the studied patient population of REDUCE-IT ®1 and where the urgency and need to treat is the highest , at a price of 1,640 SEK per month (equivalent of approximately 160 EUR or 175 USD per month**). With this approval, the Company intends to commence commercial activities in Sweden.
The role of the TLV is to evaluate all new pharmaceutical products to determine their respective reimbursement in Sweden. In addition to thoroughly examining the quality and robustness of the scientific evidence presented in reimbursement dossiers, TLV is widely regarded as utilizing some of the most sophisticated Health Technology Assessment methods and models in Europe. The Swedish decision follows the individual reimbursement in Denmark in mid-February of 2022 and marks a significant milestone for Amarin in Europe.
“A decision for reimbursement in Sweden by the TLV underscores the quality of the REDUCE-IT® study results,” stated Laurent Abuaf, senior vice president and president Amarin Europe. “Sweden is known to be at the forefront in the prevention and treatment of cardiovascular disease, as demonstrated by the SWEDEHEART registry, a unique online registry that reports the outcome of every single patient hospitalized at coronary care units for acute coronary syndrome or undergoing coronary or valvular intervention2. I am pleased that the TLV’s decision acknowledges the value of VAZKEPA to further strengthen cardiovascular care in Sweden.”
Amarin continues to progress its reimbursement discussions with national health authorities in Norway, Finland, Germany, the UK, France, Italy, Spain and The Netherlands. While discussions in Central and Eastern Europe may be impacted by local political conditions, the Company’s partnership discussions in Greece, a key market in the region, are advancing well. The Company remains on track to receive reimbursement decisions in up to eight countries and launch VAZKEPA in up to six European countries this year.
International
Outside of Europe, Amarin is also advancing its international expansion plans.
Following the acceptances of VASCEPA for regulatory review in Australia and New Zealand, the dossiers have now entered full assessment by the respective national regulatory authorities in these countries. In Israel, VASCEPA has also been accepted for regulatory review by the relevant authority, and our submission is advancing as per the local process. The Company is actively evaluating partnerships for these countries. Amarin’s partner in Middle East and North Africa (MENA), Biologix, has received the official registration certificate from the Kingdom of Saudi Arabia (KSA) regulatory authority for the treatment of severe hypertriglyceridemia. This first approval in KSA enables the preparation and submission of a variation to seek review and approval of the cardiovascular risk reduction indication. In Canada, HLS is in the final stages of the process for public plan reimbursement of VASCEPA.
Lastly, the Company and partner Edding remain on track to receive approval in Hong Kong and China this year.
The Company looks forward to providing future updates on its progress including updates regarding reimbursement decisions as part of its standard business updates, including earnings reports and U.S. SEC filings.
*U.S. Dollar
**Based on exchange rate of EUR and USD as of the date of this release.
About Amarin®
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. From our scientific research foundation to our focus on clinical trials, and now our commercial expansion, we are evolving and growing rapidly. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. We are committed to rethinking cardiovascular risk through the advancement of scientific understanding of the impact on society of significant residual risk that exists beyond traditional therapies, such as statins for cholesterol management.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first and only drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk after statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United States)
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
- Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.
Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about the market potential for VASCEPA/VAZKEPA; expectations regarding performance such as prescription growth and market access for VAZKEPA, the impact of the COVID-19 pandemic including beliefs about patient needs for VASCEPA/VAZKEPA; beliefs that Amarin's strategy for reducing the effects of cardiovascular disease is sound and that Amarin is efficiently reaching physicians, payors, pharmacists and patients; plans for Amarin's go-to-market model; the timing and outcome of regulatory reviews, recommendations and approvals and related reimbursement decisions and commercial launches in Europe and elsewhere; plans for Amarin's expected launch of VAZKEPA directly in major markets in Europe, directly and indirectly; beliefs about the cardioprotective and other benefits of VASCEPA/VAZKEPA; beliefs about the strength of data in market access dossiers and other reports; expectations for the timing, effectiveness and outcome of promotional activities, including patient-oriented campaigns, conference and posted presentations and education of healthcare professionals; commercial and international expansion and prescription growth and revenue growth and future revenue levels. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Amarin's ability to effectively commercialize VASCEPA/VAZKEPA and maintain or grow market share will depend in part on Amarin’s ability to continue to effectively finance its business, VASCEPA/VASKEPA approval in geographies outside the U.S., efforts of third parties, Amarin’s ability to create and increase market demand for VASCEPA/VASKEPA, to achieve broad market acceptance, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of VASCEPA/VASKEPA. Among the factors that could cause actual results to differ materially from those described or projected include the following: the possibility that VASCEPA/VASKEPA may not receive regulatory approval in various international geographies on expected timelines or at all; the risk that Amarin has overestimated the market potential for VASCEPA/VASKEPA i; risks associated with Amarin's expanded enterprise; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that sales may not meet expectations and related cost may increase beyond expectations. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the year ended December 31, 2021, filed on or about the date hereof. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact Information
Media Inquiries:
Communications Amarin Corporation plc
PR@amarincorp.com
Investor Inquiries:
Lisa DeFrancesco
Investor Relations Amarin Corporation plc
investor.relations@amarincorp.com
1 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380(1):11-22.
2 https://www.ucr.uu.se/swedeheart/dokument-sh/arsrapporter-sh/1-swedeheart-annual-report-2020-english-2/viewdocument/3140
